BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASSIST RAIL SET FOR ECHO BED 9153650586

    MDR report key: 4680310 · Received April 10, 2015

    Report

    Report Number
    3003433498-2015-00055
    Event Type
    Death
    Date Received
    April 10, 2015
    Date of Event
    April 1, 2015
    Report Date
    April 7, 2015
    Manufacturer
    CARROLL HEALTHCARE
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    INVACARE TERRITORY BUSINESS MANAGER (TBM) STATED THAT A FACILITY REPORTED THAT A RESIDENT WAS LAYING IN AN ECHO BED WITH THE SIDE RAIL UP AT BED TIME, WHEN THEY WENT TO CHECK ON THE RESIDENT IN THE MIDDLE OF THE NIGHT, THE RESIDENT WAS LAYING ON THE FLOOR DECEASED AND THE BED RAIL WAS NOW IN THE DOWN POSITION WITH THE RESIDENTS ARM TANGLED IN THE RAILING. THE TBM WENT TO THE FACILITY TO INVESTIGATE AND AGREED WITH THE CORONERS REPORT, THAT THE RESIDENT DIED FROM ANOTHER MEDICAL ISSUE, NOTHING TO DO WITH THE INVACARE BED SYSTEM. THE TBM STATED THAT THE BED HAS BEEN TAKEN OUT OF SERVICE. TBM HAD NO FURTHER INFORMATION TO PROVIDE. INVACARE SPOKE TO THE FACILITY AND TBM WHO STATED THAT THE DEATH WAS NOT CAUSED BY THE INVACARE PRODUCT BUT WAS DUE TO MEDICAL ISSUES. FACILITY AND TBM STATED THAT THE PRODUCT IS IN GOOD WORKING ORDER, IT WAS A MEDICAL ISSUE THAT CAUSED THE RESIDENT TO FALL OUT OF BED AND ON THE WAY DOWN THE END USERS ARM CAUGHT ON THE RAIL BUT THE RESIDENT HAD ALREADY PASSED AWAY FROM THE MEDICAL CONDITION. THERE WAS NO MALFUNCTION OF THE PRODUCT. MDR BEING FILED BASED ON THE REPORTED DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240107 ASSIST RAIL SET FOR ECHO BED 9153650586 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL CARROLL HEALTHCARE ECHO

    Patients

    Seq Age Sex Outcome Treatment
    1 Death